FDA EIR - Princeton Biomedical Research - April 11, 2000

An FDA inspection of Princeton Biomedical Research, P.A., led by Principal Investigator Dr. Jeffrey T. Apter, M.D., was conducted from April 11 to May 3, 2000. This directed, for-cause inspection, guided by FDA compliance program C.P. 7348.811, revealed several significant deficiencies across two clinical research protocols. Key violations included subjects being screened and diagnosed prior to providing informed consent, which contravened protocol requirements. Diagnoses were frequently made by non-physician raters, and physician sign-offs on patient visits often did not correspond with their actual presence or the visit dates. Physical examinations were performed by a Physician's Assistant without obtaining necessary sponsor approval.

Furthermore, research source documentation was inadequate, exhibiting altered or overwritten dates, lacking contemporaneous updates, and failing to consistently document the Principal Investigator's presence or supervision of protocol-required activities. Enrollment eligibility test scores were changed without supporting explanations. Adverse event reporting was also deficient, as causal relationships were not consistently rated by physicians as mandated by protocol and sponsor requirements, and documentation lacked clear accountability for assessments. There was also an absence of source documentation to confirm screening for prior investigational drug treatment.

Corrective actions and recommendations included documenting all changes with initials and dates, obtaining written sponsor approvals for delegate roles, ensuring proper physician oversight and presence during study activities, improving adverse event rating documentation, and updating screening forms to include prior drug history. Dr. Apter was also reminded of his obligation to ensure that utilized Institutional Review Boards (IRBs) complied with regulatory requirements.